U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implant, cochlear - Product Code MCM
Causa
Cochlear americas is recalling nucleus sterile silicone template ci24re/ci422 part number z421736 because expired product was distributed.
Acción
Cochlear sent an Urgent Medical Device Recall letter dated June 5, 2015 via Fed-Ex shipment. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return affected products for replacement.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
cochlear implant - Product Code MCM
Causa
Mistuned headpiece - advanced bionics recently became aware of a tuning issue with some platinum series and s-series
headpieces shipped from may 2007 through april 2008. tuning refers to the process through which the headpiece's communication
frequency is adjusted to match that of the internal device. potential clinical
symptoms include:
-no lock
-intermittent lock
-implant locks, but cann.
Acción
Advanced Bionics is notifying clinicians of this situation so that they can provide
appropriate clinical management. The notification letter sent to clinicians in the
United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not
affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device.
Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the
number of headpiece-related complaints, firm advises of the potential clinical
symptoms:
-No lock
-Intermittent lock
-Implant locks, but cannot measure impedances
-Reduction in battery life, primarily for C1 patients with thick flaps.
Per the letter, as long as the system maintains lock, there is no degradation in sound quality or
stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal.
Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected
headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stimulator, nerve - Product Code ETN
Causa
Mislabeled outer carton:
monopolar probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm.
Acción
Spine Wave sent an Urgent: Medical Device Recall letter dated June 11, 2015 to affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to acknowledge receipt
of notification by returning the enclosed Recall Notice Acknowledgement Form in the stamped envelope provided.
For questions, contact Spine Wave directly at 203-944-9494
and ask for the Recall Coordinator or by email at rsmith@spinewave.com.